Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT06197581

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-08-21

148

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy,despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall / breast ± lymphatic drainage area and requiring capecitabine, CDK 4/ 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.

CONDITIONS

Official Title

Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status 0-2
  • Age between 18 and 70 years old
  • Pathologically diagnosed with breast cancer
  • Requires radiotherapy including chest wall/breast with or without lymph node regions
  • Planned treatment with capecitabine, CDK4/6 inhibitor, PARP inhibitor, immune checkpoint inhibitors, or HER2 inhibitors according to guidelines
Not Eligible

You will not qualify if you...

  • Male breast cancer
  • Allergy to any of the study medications
  • Will receive trastuzumab alone during and/or after radiotherapy
  • Presence of severe other diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

Y

Yirui Zhai, MD

CONTACT

B

Bo Lan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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